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Home Access - 1st Generation ELISA?

Jul 11, 2001

Dr. Holodniy,

I had a question about the reliability of Home Access. I called the company and was told by a company representative they use a 1st generation ELISA. If this is the case, how can they claim their test is as accurate as one performed in a physician's office or hospital when the majority of them are using 3rd generation HIV1/2 combo tests? My understanding is the 3rd generation ELISAs are much more sensitive and decrease the window period even further. I would assume Home Access is still using the same ELISA they used to gain FDA approval back in 1996 or 1997. It is surprising they would not make any modifications/improvements over the past 5 years when everyone else is upgrading their tests. In your opinion can the general public still feel confident in a result from Home Access?

Your response would be helpful to all!

Response from Dr. Holodniy

See question and response to home access test from 7/9/01



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